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Comparison Between spIgE and Skin Prick Test of Local and Imported Aeroallergens

Primary Purpose

Immediate Hypersensitivity

Status

Completed

Phase

Not Applicable

Locations

Thailand

Study Type

Interventional

Intervention

Skin prick test

specific IgE measurement

About this trial

This is an interventional diagnostic trial for Immediate Hypersensitivity

Eligibility Criteria

10 Years - 60 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Patient with controlled Asthma and/or AR (mild to moderate severity) who were diagnosed in Allergy clinic and ENT clinic, Siriraj hospital
SPT positve one of American Cockroach, House dust mite, cat, dog and mold.
Patient were consented to trial.

Exclusion Criteria:

Chronic disease such as heart disease, liver, renal and severe sepsis
History of anaphylaxis
Skin rash
Pregnancy

Sites / Locations

Faculty of Medicine Siriraj Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Skin prick test with aeroallergens

specific IgE measurement

Arm Description

Mean wheal diameters of SPT with commercial and local American coakroach, house dust mite, cat, dog and mold

specific IgE levels of commercial and local American coakroach, house dust mite, cat, dog and mold

Outcomes

Primary Outcome Measures

mean wheal diameter of SPT of local and imported allergen extracts and specific IgE levels

measure and compare SPT result of local and imported allergen extracts

Secondary Outcome Measures

Full Information

NCT ID

NCT02561390

First Posted

September 15, 2015

Last Updated

May 2, 2016

Sponsor

Mahidol University

1. Study Identification

Unique Protocol Identification Number

NCT02561390

Brief Title

Comparison Between spIgE and Skin Prick Test of Local and Imported Aeroallergens

Official Title

In-vivo Potency Evaluation of American Cockroach, Dog, Cat, Dust Mites and Mold Allergen Extracts Produced by Siriraj Hospital Comparing With Imported Extracts by Using Skin Prick Test.

Study Type

Interventional

2. Study Status

Record Verification Date

May 2016

Overall Recruitment Status

Completed

Study Start Date

November 2013 (undefined)

Primary Completion Date

June 2014 (Actual)

Study Completion Date

June 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Mahidol University

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The prevalence of Allergic rhinitis(AR) and asthma was increased world wide. In 1998, ISAAC found that prevalence of AR and asthma inThailand was in moderately high group. Tests for immediated reaction SPT and spIgE, were used for evaluated sensitization of allergen in patient. They guided the investigators for proper management as well as patient education. Clinician will use the result for choose allergen in case that might need immunotherapy. SPT is safe and more economic for patient. Specific IgE has an advantage in patient who cannot withhold antihistamine prior SPT. In United state had a trial of result between SPT and spIgE for cockroach, cat, house dust mite and mold. It showed the correlation between two tests. In Thailand, the investigators haven't had data about it yet.

Detailed Description

SPT and specific IgE for allergens is necessary for allergen avoidance and specific immunotherapy. To have local allergen extracts will help the patients to easier get the appropriate management

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Immediate Hypersensitivity

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

84 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Skin prick test with aeroallergens

Arm Type

Experimental

Arm Description

Mean wheal diameters of SPT with commercial and local American coakroach, house dust mite, cat, dog and mold

Arm Title

specific IgE measurement

Arm Type

Experimental

Arm Description

specific IgE levels of commercial and local American coakroach, house dust mite, cat, dog and mold

Intervention Type

Procedure

Intervention Name(s)

Skin prick test

Intervention Description

skin prick test to American cockroach, dog, cat, dust mite and mold allergen extracts are performed

Intervention Type

Other

Intervention Name(s)

specific IgE measurement

Intervention Description

measure specific IgE of American cockroach, dog, cat, dust mite and mold

Primary Outcome Measure Information:

Title

mean wheal diameter of SPT of local and imported allergen extracts and specific IgE levels

Description

measure and compare SPT result of local and imported allergen extracts

Time Frame

18 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

10 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patient with controlled Asthma and/or AR (mild to moderate severity) who were diagnosed in Allergy clinic and ENT clinic, Siriraj hospital SPT positve one of American Cockroach, House dust mite, cat, dog and mold. Patient were consented to trial. Exclusion Criteria: Chronic disease such as heart disease, liver, renal and severe sepsis History of anaphylaxis Skin rash Pregnancy

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Nualanong Visitsunthorn, Prof

Organizational Affiliation

Mahidol University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Faculty of Medicine Siriraj Hospital

City

Bangkoknoi

State/Province

Bangkok

ZIP/Postal Code

10700

Country

Thailand

12. IPD Sharing Statement

Citations:

PubMed Identifier

9643741

Citation

Worldwide variation in prevalence of symptoms of asthma, allergic rhinoconjunctivitis, and atopic eczema: ISAAC. The International Study of Asthma and Allergies in Childhood (ISAAC) Steering Committee. Lancet. 1998 Apr 25;351(9111):1225-32.

Results Reference

background

PubMed Identifier

9623008

Citation

Vichyanond P, Jirapongsananuruk O, Visitsuntorn N, Tuchinda M. Prevalence of asthma, rhinitis and eczema in children from the Bangkok area using the ISAAC (International Study for Asthma and Allergy in Children) questionnaires. J Med Assoc Thai. 1998 Mar;81(3):175-84.

Results Reference

background

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Comparison Between spIgE and Skin Prick Test of Local and Imported Aeroallergens

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